What are the key elements of the ISO 13485 standard?

To obtain a CE marking—which indicates conformity with safety standards for products sold in the European Economic Area—medical device manufacturers must either obtain certification with a notified body or have a quality system in place.

ISO 13485 is a certification for the medical device industry and it effectively covers ISO 9001 with a few additional requirements. However, many medical device manufacturers fail to adequately assess major ISO 13485 requirements prior to starting the certification process.

What can your organization do to get a step ahead?

5 Key Elements of the ISO 13485 Standard

As an industry-leading quality management system provider, Qualio has helped hundreds of life sciences organizations orient toward rapid and sustained ISO 13485 certification.

But don't just take our word for it...

Without Qualio, we would have not been able to achieve our critical milestone of ISO 13485 certification before the end of 2015. We are now prepared to take next steps towards compliance with European regulatory requirements. —Jonas T., Quality Manager.

With that in mind, here are the five key elements of the ISO 13485 standard.

1. Quality Management System

This section talks about general quality management system requirements, as well as the documentation needed to implement and maintain an effective quality management system. According to ISO, organizations need to:

  • Determine the processes the quality management system requires and what's needed to apply these processes throughout the organization, taking into account the various roles involved,
  • Apply a risk-based approach to the control of the appropriate processes needed for the quality management system, and
  • Determine the sequence and interaction of these processes.

RELATED READING: The Essential Parts of an ISO 13485 Medical Device Quality Management System

2. Management Responsibility

This section outlines the unique roles and responsibilities of management as it pertains to quality management system implementation and maintenance.

In short, management should provide evidence of its commitment to the development and maintenance of the quality management system and its effectiveness. To do that:

  • Communicate the importance of meeting regulatory requirements
  • Establish high-value quality policy
  • Ensure that quality objectives are established
  • Conduct management reviews
  • Ensure availability of quality management system resources

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3. Resource Management

This phase outlines the resources life sciences organizations should commit to implement the quality management system and maintain system effectiveness. It outlines the provisions needed to meet major regulatory and customer requirements.

Resources outlined in this section include:

  • The provision of resources
  • Human resources
  • Infrastructure
  • Work environment
  • Contamination control

RELATED READING: What is a Document Control System and Why Does it Matter?

4. Product Realization

In a rush to get products into development as soon as possible, many organizations often overlook the planning phase. Section 7.1 requires that you appropriately plan your realization efforts.

More specifically, it states that you should:

  • Establish the quality requirements for your product(s)
  • Define what your required processes will be and what supporting documentation will be needed for those processes
  • Outline the company infrastructure that will need to be created and what the work environment should be like
  • Define employee qualification and training requirements
  • Establish your processes for verification, validation, measurement, monitoring, handling, inspection, storage, distribution, and traceability

Finally, you have to organize all of that information in such a way that it can be easily accessed and understood.

5. Measurement, Analysis, and Improvement

According to ISO, "the organization shall plan and implement the monitor, measurement, analysis, and improvement processes" related to the quality management system and products.

In this pursuit, organizations need to:

  • Demonstrate conformity of product
  • Ensure conformity of the quality management system
  • Maintain the effectiveness of the quality management system

RELATED READING: 4 Examples of Continuous Improvement in Quality

Adopt and Implement a Quality Management System

A quality management system offers a diverse range of business benefits. But like any other piece of technology, they're not a magic potion.

Implementing a quality management system cannot cure an organization that isn't led by quality-driven management. Successfully shifting to a quality-driven culture requires full support from the leadership team and a commitment to change.

To streamline system adoption and master ISO 13485 certification, we recommend downloading our free guide on the topic. Read it to learn about everything you need to know about preparing for ISO 13485, including:

  • What the ISO 13485 certification is
  • The differences between ISO 13485 and ISO 9001
  • 98 steps to prepare for ISO 13485 certification
  • Getting started with Qualio

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Published by Kelly Stanton January 5, 2021
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